KR101886463B1 - Childproof highly-inert bag packaging for individually dosed films containing an active ingredient - Google Patents

Abstract

The present invention relates to a pouch made by sealing, which is a pouch having at least on each face at least a cover layer comprising at least one face on top of one or more faces, A child resistant package for a dosage form, said local weakened portion (4) extending in an arc or curved path around the single dose (1) and covering an angular range of more than 90 degrees as viewed from the center of gravity of the single dose To form a continuous pattern. ≪ Desc / Clms Page number 2 >

Description

≪ Desc / Clms Page number 1 > CHILDPROOF HIGHLY-INERT BAG PACKAGING FOR INDIVIDUALLY DOSED FILMS CONTAINING AN ACTIVE INGREDIENT FOR IN-

The present invention relates to a child safe high inert pouch for a single administration film containing the active ingredient.

For general use, it is often necessary to package medicines individually as a single dose. This is in particular because this kind of individual packaging ensures that the given single dose is taken at the desired time and that accidental dosing of the single dose is prevented.

It also protects the medicines from environmental impacts. In containers that hold multiple doses, the lifetime of the contents as a whole is often adversely affected by the repeated opening required to separate single doses. This adverse effect is a much higher degree of mechanical and chemical sensitivity of the medicine.

Moreover, the requirements that are often met to ensure the safety of medicines are to protect non-target groups, especially children, from accidental dosing. An additional factor related to this is the natural curiosity of the child, which is often seen as asking to be opened, and as a result the stimulus to opening the packaging can result in the child being exposed to dangerous substances.

On the other hand, it is important that the packaging material can be easily opened by the intended target group, in most cases by the elderly. This issue is briefly described by the expression "child resistance, elderly friendly".

Film shaped medicines present certain challenges because they are sensitive to chemical loads (moisture, oxygen) and physical loads. Because film-shaped medicines generally have a large surface area to be suitable for pharmaceutical applications, typically oral applications, and packaging materials must always seal all surfaces of the products they contain, the film-shaped medicinal packaging material needs to be relatively large .

In order to achieve the required protective effect, it is often necessary to use a film which is referred to as a high-barrier film, for example a film commercially available in the form of Pfizer's Sudafed PE film. These have the disadvantage that they are expensive, especially since more than twice as much packaging material as a packaged product must be used for one package to completely seal one product. Thus, it is almost impossible to avoid the adverse cost of packaging versus product cost, which negatively affects the price of the final product.

Child safety film packaging materials for pharmaceutical oral dosage forms based on the use of peelable pouches made of two films, each of which is made by heat sealing and each contain a thin aluminum layer, imparting the required chemical protection is already known. However, such film packaging material often contains incisions that are not cut through the pouch surface itself. As a result, the packaging material must be folded 90 [deg.] In the middle of the incision to form a tear nick on the side of the package. In this manner, the two film portions can be pulled from each other by creating a tear in the wrapping material to expose opening assist means for gripping.

This packaging material has the disadvantage that, in principle, the time required for manufacturing such a packaging material is quite long and relatively high expenditure is required from the viewpoint of materials, which is very expensive.

In addition, a pair of peelable < RTI ID = 0.0 > peelable < / RTI > peelable < RTI ID = 0.0 > There are additional technical solutions based on films and non-paired peelable films.

All of the described solutions share that they are based on strippable films, that is, some of the film structures touching the article must be strippable. Generally, there is always a polyethylene-based release layer or similar configuration with relatively weak seal seam strength to be releasable.

These films often do not exhibit inertness to the movement of the active ingredient, and as a result have the disadvantage that during storage the active ingredient migrates into the packaging material and is extracted from the medicament. Further, the strength of the sealing joint is typically reduced by the fact that the sealed polymer is weakened by the introduction of other components that can not be welded. The side effects of these adjuvants are reduced sealing seam impermeability to gases, such as water vapor and oxygen, and this side effect is due to the reduced storage stability of the packaging material, resulting in increased moisture absorption of hygroscopic products and increased degradation of oxygen sensitive products Can lead to problems.

International Patent Application Publication No. WO 2010/091813 A1 describes pouches provided for film shaped medicines and ensuring tear properties of the pouches through a line of weakness. The combination of folding and lining on the vulnerable lines allows one side of the package to be opened per vulnerable line to access the product from this side of the pouch.

Thus, in order to expose two or three sides of the product, a combination of two or three movements of folding and lining must be performed along the lines of weakness. This is especially true if the medication is urgently needed, for example, if it is painful, if there is solicitation or in special emergency situations, or if the required medication is not given, or if it causes worst case death If so, it can be seen as a cumbersome process.

It is an object of the present invention to overcome the above-mentioned disadvantages and to enable a child-resistant single-dose packaging material that is based on a sealed film and allows single-motion opening to expose three sides of the product in a single motion.

Preferred embodiments have the additional advantage that they have a minimum amount of film consumption per dose and exhibit inertness to movement of the active ingredient and have a sealing seam that does not need to meet any maximum sealing seam strength.

The object is achieved by a method of producing an outer cover layer, particularly an outer cover layer having at least one side, preferably both sides, of a topically weakened portion having a minimum tear resistance of 30 N and not touching the rim of the package, Is achieved by the packaging material according to claim 1, which accommodates a single capacity in the pouch having it. The locally weakened portion forms a continuous pattern extending into an arc or curved path around the single capacitance, and the single capacitance is located at the center of the bent or curved path. When viewed from the center of gravity of the single dose, the local weakness covers an angular range of 90 DEG or more, preferably 120 DEG or more, particularly preferably 180 DEG or more, where the local weakness is preferably designed as a fragile line.

The local vulnerability extends most (but at least completely outside the start region and the end region) in the secret area, which also includes the single dose. At the rim, the wrapper is preferably completely surrounded by continuous sealing seams.

The arc indicated by the local weakness can have a different radius of curvature, but preferably it does not have an edge or a radius of curvature of less than 1 mm, particularly preferably a radius of curvature of less than 1 cm.

In this way, the opening of the packaging material is advantageously influenced by tearing and opening the packaging material in the local weakened portion in a single motion.

In a preferred embodiment, the local vulnerability is selected such that the local vulnerability is extended or extended at least from its starting and ending regions by 5 cm or less, preferably by 2 cm or less, particularly preferably by 1 cm or less from the outline of the single- It is designed in such a way.

In another preferred embodiment, the topical fragile portion is at least partially expanded in such a manner that the package is torn alongside the fragile portion to open and then expose portions of the single dose.

In a preferred embodiment, both sides of the outer layer contain local weaknesses, in which case the weak areas on both sides preferably coincide.

 The line of weakness preferably has a shape which allows the product in the pouch to be exposed on three sides by allowing the tear direction change twice at an angle of 45 degrees or more, particularly preferably at an angle of 75 degrees or more.

In a preferred embodiment, the weakened portion is formed by selective weakening of the cover layer, rather than being formed by an entire cover layer or an incision extending through the two cover layers.

In a preferred embodiment, tear initiation is allowed only after the pouch has been folded at a defined line.

The outer cover layer can preferably be printed. In particular, it has a mark that clearly states the tear-off mechanism to prevent delays caused by learning of the release mechanism in an emergency. The cover layer preferably has an arrow marking the local vulnerability and indicating the tear opening direction.

In a preferred embodiment, a metal layer, in particular a highly impermeable metallic layer, preferably aluminum, is located on at least one side of the pouch, preferably between both side cover layers and the single capacitance, And protrudes into the sealing surface.

This embodiment has the advantage that the pouch surface exhibits inertness with respect to movement of the active component, gas exchange and water vapor.

In another preferred embodiment, the inner sealing layer, in particular the inner sealing layer contacting the article, is located on at least one side of the pouch, preferably between the outer cover layer and the single-side volume on both sides, or between the metallic layer and the single- The inner sealing layer can form solid and gas impermeable sealing seams that are completely covered by the outer cover layer.

The outer cover layer, the sealing layer and, if appropriate, the metal layer are preferably fixedly connected to one another, preferably in the form of a laminate.

In a preferred embodiment, the sealing layer is present only in the region of the sealing joint, so that the cover layer or, if appropriate, the metallic layer is in direct contact with the single capacity. This embodiment has the additional advantage that it has a sealing seam showing inertness to the movement of the active ingredient.

In a preferred embodiment, the tearing can be initiated by a second weakened portion in the form of an incision, and the second weakened portion can rest on the periphery of the pouch by folding along a folding line existing within the pouch and traversing the incision. Particularly preferably, the second weakened portion has the form of a side incision. Of course, this side incision does not reach as far as the rim of the package.

In the case of the second vulnerability, the two cover layers are weakened in such a way as to ensure that the tear initiated by the cut can occur along the intended path, preferably by performing laser processing or other suitable cutting methods.

 A tear-off stopper, especially a Y-shaped piece, for stopping the tearing is preferably present in the second weakened portion. The initiation region and / or the termination region of the locally weakened portion are preferably formed such that they act as a tearing-off agent.

The vulnerability of the Y-geometry type in the second vulnerability is preferably achieved by laser treatment. This Y slice of the vulnerable line allows the interruption of the heat after the initial tear in the second vulnerable and allows for targeted induction along a defined tear path. The Y slice functions as a tear-off agent.

Another preferred embodiment has one branch of the Y-shape on one side (e.g., top side) of the cover layer and another branch on the opposite side (e.g., bottom), in which case the two sides, Superposition of top and bottom completes Y. This change permits a particularly short cycle time during manufacture.

In a preferred embodiment, the packaging material is symmetrical, and in particular the topical fragile portion is symmetrical. In this manner, the pouch can be easily opened by a right-handed person and a left-handed person and provides a second openability if the first attempt to open the package fails.

Another preferred embodiment contains, in particular, a mechanism in the form of a further fragile line, which provides a second opportunity to open the package in case of failure.

An advantageous feature is in particular on the curved path which makes it possible to derive the tear profile with a suitable combination of radius of curvature and cover layer material after the start of the tear so that several faces of the product are exposed in a single movement, In the specific design of. To this end, a particularly preferred embodiment, as shown in the figures, is characterized in that the tear initiation is carried out by a side incision and the subsequent interruption and induction of phosphorus along the intended curved path is carried out by a Y- And the line exposes three sides of the product.

It is particularly preferred that the lines of weakness are applied coincidentally on both sides of the pouch, in which case the upper and lower webs of the pouch are made of the same material. However, the present invention also encompasses the possibility that the vulnerable line may be applied on only one side. In this case, the function may be made easier by a suitable choice of material, for example, the fact that the non-weakened surface is made of a material with lower tear resistance than the topically weakened top surface.

A preferred method of weakening the cover layer is laser cutting. By using laser light of sufficiently focused power, the outer plastic layer can be locally burned and removed very precisely without damaging any metal layer that may be present. The barrier effect of the metal film is preserved in this way.

Examples of the packaging material according to the present invention are shown in the drawings and described below.

Figure 1 shows a schematic view of a preferred packaging material.
Figures 2a and 2b show different tear direction transitions.
Figure 3 shows a schematic view of the opening of the preferred packaging material.
Figure 4 shows a schematic view of a cover layer with indicia for indicating opening.
Figure 5 shows top and bottom views of a preferred embodiment.

An example of a packaging material according to the present invention for single dose 1 is shown in Fig. The packaging material is preferably made from a high-barrier film by heat sealing. These high-blocker films are particularly constructed on the basis of an aluminum film having a thickness of preferably 9 [mu] m to 20 [mu] m, which ensures substantial impermeability and inertness.

To produce such a pouch, two aluminum films are adhesively bonded or welded to one another in the region of the sealing seam 3, which is made from standard materials known to those skilled in the art, preferably PVC, PVDC, PP, Barex Barex (British Petroleum), PE, Aclar (Honeywell), Topas-COC (Topas Advanced Polymers) and Surlyn, And a laminate heat-sealable plastic layer which is composed of a material selected from the group consisting of silicon dioxide, and preferably serves as a sealing layer having a thickness of 20 [mu] m to 100 [mu] m. This sealing layer is typically laminated with an aluminum layer, resulting in a layer that automatically contacts the product as a result of the pouch structure. The higher the inertness of the material, the more favorable the product stability.

The outer side of the packaging film is formed by an outer cover layer having a tear resistance which is sufficiently high to ensure that passive tear-free opening can not be possible without the use of auxiliary means in the absence of local weak areas. A preferred material for this is a PET having a thickness of 10 mu m to 100 mu m, preferably 10 mu m to 50 mu m.

A particularly preferred packaging material (from inside to outside) has the following structure: Barex having a thickness of 20 [mu] m to 40 [mu] m as a sealing layer on the face facing the single dose; A metal layer and finally aluminum having a thickness of 9 to 25 占 퐉 as an outer cover layer; And PET having a thickness of 10 mu m to 100 mu m, preferably 10 mu m to 50 mu m. The outer cover layer may be printed arbitrarily to identify the product. Inside the packaging material, the single dose (1) is located in the secret sealed area (2). In the region where this secret-sealed region is located, the cover layer or two cover layers have a fragile line 4 partially surrounding the single capacitance 1 in the form of an arc.

From the center of gravity of the single dose, this arc covers an angular range of more than 180 degrees. The arc may have a different tear direction change. Figures 2a and 2b show two possible tear direction transitions. In FIG. 2A, the tear direction change is measured at 85 DEG, and in FIG. 2B, the tear direction change is measured at 90 DEG.

An example of the design according to Figure 2B is a packaging material consisting of a pouch, wherein the upper surface of the pouch is made of PET with a thickness measured from 10 m to 100 m, preferably from 10 m to 50 m, And Barex having a thickness measured from 28 [mu] m to 50 [mu] m, and is provided with a weakening line by laser treatment, and the lower surface of the pouch is made of PET (0 탆 to 12 탆), aluminum Barex (28 占 퐉) and is not treated with a laser. The tear behavior is similar in principle but does not follow the curve very accurately, but it is easier to generate because only one side needs to be treated with a laser. The curved line is to be designed with a suitable choice of radius so that the tear direction is reliably up to 90 °. For example, if the pouch size is between 45 and 65 mm, a radius of curvature of 20 mm has been found suitable. The tear direction change need not reach 90 [deg.], But instead it may be advantageous to reach a slightly smaller angle, e.g., 85 [deg.], As shown in Figure 2a. This can be achieved by the fact that the curve can be made trapezoidal.

In this example, the beginning and end regions of the vulnerability line lie within the sealed region. Such a pouch can not be manually opened without the aid of a dissecting tool, the sealing seam can not be opened, and the film itself can not be torn due to the stability of the outer cover layer. As shown in Fig. 3, passive unsealing is achieved by targeted localized weakening of the surrounding cover layer, which does not touch the periphery of the package. Only when the wrapping material is folded along the folding line (6), the topical weakening part (4) touches the rim of the (folded) wrapping material, for example to allow tearing at the side incision (5).

As shown in Fig. 4, the cover layer may contain members (arrows) indicating the opening mechanism, weakening or opening direction.

As shown in Fig. 5, the topical weakness can have a different shape on the top surface 7 and the bottom surface 8 of the package. For example, the fragile portion 4 can be designed so that a Y-shaped region, which acts only to stop the tearing only when two pieces of packaging material overlap, is obtained in the start region and the end region of the fragile portion. This saves time during manufacturing.

Claims (10)

What is claimed is: 1. A child safety package for a single dose, the pouch being made by sealing, the pouch having at least a cover layer on at least one face with a weakness on one or more sides that does not touch the rim of the package, Characterized in that said localized vulnerability extends in a circular or curvilinear path around the single dose and forms a continuous pattern covering an angular range of 90 DEG or more when viewed from the center of gravity of the single dose. The method according to claim 1,
Characterized in that the locally weakened portion is extended in at least a confined area including a single dose and is designed as a line of weakness. 3. The method according to claim 1 or 2,
Characterized in that the arc indicated by the local weakness does not have a corner or a radius of curvature of less than 1 mm and the tear direction change is less than 90 degrees. 3. The method according to claim 1 or 2,
Characterized in that it further comprises at least one metal layer and further comprises at least one sealing layer. 3. The method according to claim 1 or 2,
The method of claim 1, further comprising a side sidecut that does not reach as far as the rim of the package in the start area, the end area, or the start area and the end area of the local vulnerability, A child safety packaging material characterized by being designed in the form of a child safety packaging material. 3. The method according to claim 1 or 2,
Characterized in that the locally weakened portion is designed in such a way that it is extended at least 5 cm or less from the outline of the single dose, except for at least its start and end regions. 3. The method according to claim 1 or 2,
Characterized in that the locally weakened portion has a symmetrical shape. 3. The method according to claim 1 or 2,
And a mechanism for providing a second opportunity to open the package when the first attempt to open the package fails. 3. The method according to claim 1 or 2,
Wherein the combination of the radius of curvature of the local weakened portion and the material of the cover layer enables the starting tear profile to be induced so that multiple faces of the product are exposed in a single motion. 3. The method according to claim 1 or 2,
Characterized in that the tear-off initiation is carried out by lateral incision and the subsequent break and induction of phosphorus along the intended curved path is carried out by the Y-piece of the vulnerable line, so that the U- Child safe packaging materials.

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